Scientist I, DRUG PRODUCT DEVELOPMENT - VACCINE BU
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda.Join us as an Scientist I, Drug Product Development - Vaccine BU in our Cambridge, MA office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Design, manage and execute studies pertaining to vaccine drug product formulation and process development including optimization, characterization, scale-up of manufacturing processes from the R&D laboratory stage through to Commercial production.
- Design, manage and execute studies pertaining to vaccine drug product formulation and process development including optimization, characterization, scale-up of manufacturing processes from the R&D laboratory stage through to Commercial production.
- Analyze data from studies, method development, or tech transfer activities, and author reports for submission to multiple parties, including regulatory agencies such as FDA and EMA
- Oversee programs conducted both in-house and at CMOs.
- Develop and test formulations to improve drug product stability, facilitate manufacturing processes, prolong shelf life, and set product specifications.
- Design and implement protocols for drug product stability studies, both long-term and accelerated conditions.
- Design and execute in-use stability/studies of Drug product including compatibility with administration components to define handling instructions and in-use hold times during dose preparation and administration.
- Design and execute or oversee studies to support life cycle management activities.
- Coordinate efforts between different teams, e.g. Process Development, Vaccine Research and Analytical, including scheduling and compilation of data as it becomes available.
- Coordinate product and process characterization studies off-site with various CMOs and prepare reports for global regulatory submissions.
- Author and review CMC documentation, including technical and quality sections, for submission to regulatory agencies, e.g., IND, CTD.
- Participate in scientific conferences and/or author manuscripts for submission to scientific journals.
- Write and maintain accurate, complete, and timely data in laboratory notebooks.
- Other duties as assigned.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- PhD in Chemistry, Pharmaceutics, or Life sciences with experience of 0-2 years in pharmaceuticals, biologics or industry experience, or an MS in Chemistry, Pharmaceutics, or Life sciences with a minimum of 8 years in pharmaceuticals, biologics or industry experience.
- 2 or more years experience in Drug Product Development.
- Experience in Vaccines and/or Biologics Formulation development desired
- Experience in a GMP manufacturing environment would be preferable.
- Exposure to all aspects of the R&D process.
- Well-developed knowledge of cGMP practices as applicable to formulation, analytical development, technology transfer, or manufacturing.
- Experience in late-phase and commercial process development, tech-transfer, scale-up, process optimization, and validation.
- Demonstrated technical proficiency, scientific creativity, collaboration with others, and independent thought in suggesting experimental design and research strategy.
- Familiarity with current applicable scientific literature and applicability to various projects.
- Ability to recognize anomalous and inconsistent results and interpret experimental outcomes.
- Exhibit and promote Takeda Core Competencies.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Typical office and laboratory bending, stooping, lifting requirements apply.
- Lifting and moving supplies and equipment (up to 50 pounds).
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 20% travel.
Location and Salary Information:
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work Policy.
Salary Range: $81,900 to $117,000, based on candidate's professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
Empowering Our People to Shine
Discover more at takedajobs.com
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Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.Locations
Boston, MAWorker Type